ISO 9001:2000 Documentation Requirements Based on ISO/TC 176/SC 2 March 2001 ISO 9001:2000

Two of the Most Important Objectives in the Revision of the ISO 9000- Standard To develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations For the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities

ISO 9001:2000 Significantly reduces documentation requirements Is much less prescriptive Allows more flexibility in choice of documentation system It is stressed that ISO 9001 requires (and has always required) a “Documented quality management system”, and not a “system of documents”.

ISO 9001:2000 Enables each organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its quality management system

What Is a Document? Communication of information Evidence of conformity Knowledge sharing Main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.

Communication of Information The type and extent of the documentation will depend on the nature of the organization’s products and processes The degree of formality of communication systems The level of communication skills The organizational structure

Evidence of Conformity Provision of evidence that what was planned has actually been done. Say what you do, do what you say and prove it.

Knowledge Sharing In order to disseminate and preserve the organization’s experiences. Example: a technical specification, which can be used as a base for design and development of a new product.

Document Mediums Paper Magnetic Electronic Photographic Master Sample Other Users are also referred to ISO/TR 10013 “Guidelines for quality management systems documentation” for further guidance.

Clause 4.1, General Requirements Documented statements of quality policy and quality objectives A quality manual Documented procedures required by the international standard Documents needed by the organization to ensure effective planning, operation and control of its processes Records required by the international standard The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure” the procedure has to be established, documented, implemented and maintained.

Documented Statements of Quality Policy (1 of 2) Defined in Clause 5.3 Appropriate to the purpose of the organization Includes a commitment to comply with requirements and continually improve the effectiveness of the Quality Management System A framework for establishing and quality objectives

Documented Statements of Quality Policy (2 of 2) Defined in Clause 5.3 Is communicated and understood within the organization Is reviewed for continuing suitability Quality Policy must be measurable

Documented Statements of Quality Objectives Defined in Clause 5.4.1 Includes those needed to meet requirements for product [Clause 7.1] Are established at relevant functions and levels within the organization Are measurable and consistent with Quality Policy

Quality Manual Minimum content specified in Clause 4.2.2 Scope of the Quality Management System, including details of and justification for any exclusions Documented procedures established for the QMS, or references to them Description of the interaction between processes of the QMS

Quality Manual-Structure Structure of the manual is a decision for the organization based on: Organization’s size Organization’s complexity Organization’s culture Controlled in accordance with the requirements of Clause 4.2.3

Documented Procedures Required by ISO 9001:2000 Control of documents (Clause 4.2.3) Control of records (Clause 4.2.4) Internal Audit (Clause 8.2.2) Control of nonconforming product (Clause 8.3) Corrective action (Clause 8.5.2) Preventive Action (Clause 8.5.3)

Documents Needed by the Organization Specifically referenced in ISO 9001:2000 Quality policy (Clause 4.2.1a) Quality objectives (Clause 4.2.1a) Quality Manual (Clause 4.2.1b)

Additional Documentation There are several requirements of ISO 9001:2000 where an organization could add value to its Quality Management System and demonstrate conformity by the preparation of other documents

Additional Documentation Process maps, process flow charts,and/or process descriptions Organization charts Specifications Work and/or test instructions Production schedules Approved suppliers lists Test and inspection plans Quality plans

Documented Procedures Controlled in accordance with Clause 4.2.3 May combine the procedure for several activities into one document May require more than one document for a single procedure May require additional procedures in order to implement an effective QMS

Records Requirements for control of records are different from those for other documents All records have to be controlled in accordance with the requirements of Clause 4.2.4 Organization are free to develop records that may be needed to demonstrate conformity of their processes, products, and QMS

Required Records (1 0f 2) Management reviews (5.6.1) Education, training, skills and experience (6.2.2e) Evidence that the realization processes and resulting product fulfill requirements (7.1d) Design and development inputs (7.3.2) Results of design and development reviews (7.3.4) Results of design and development verification Results of design and development validation Results of review of design and development changes (7.3.7)

Required Records (2 of 2) Results of supplier evaluations (7.4.1) To demonstrate process validity where output cannot be measured (7.5.2d) The unique identification of a product (7.5.3) Customer property (7.5.4) Basis for calibration of measuring equipment (7.6a) Results of calibration (7.6) Internal audits (8.2.2) Release of product (8.2.2) Nonconforming product (8.3) Results of corrective action (8.5.2) Results of preventive action (8.5.3)

Preparing to Implement a QMS Process approach Identify the processes necessary for effective implementation Understand interactions between these processes Document the processes to assure effective operation and control

Processes Include Management Resources Product realization Measurement

Process Analysis Should be driving force for defining amount of documentation, taking into account the requirements of ISO 9001:2000 Should not be the documentation that drives the processes

Demonstrating Conformity With ISO 9001:2000 May not need extensive documentation Must be able to provide objective evidence of effectiveness of processes and quality management system

Objective Evidence Data supporting the existence or verity of something (Clause 3.8.1 of ISO 9000:2000) May be obtained through observation, measurement, test or other means Does not necessarily depend on documented procedures, records or other documents except where specifically required by ISO 9001:2000

Objective Evidence Where the organization has no specific procedure for a particular activity, and this is not required by specification, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2000 Example: Internal and external audits

Terms and Definitions Document - information and its supporting medium (ISO 9000:2000 Clause 3.7.2) Procedure – Specified way to carry out an activity (3.7.4) Quality Manual – Document specifying the quality management system of an organization Quality Plan – document specifying which procedures and associated resources shall be applied, by whom and when to a specific project (3.7.5) Record – document stating results achieved or providing evidence of activities performed (3.7.6) Specification – document stating requirements

Bibliography Guidance on the Documentation Requirements of ISO 9001:2000 ISO/TC 176/SC 2/N525R March 2001 Quality Management Systems – Requirements ISO/FDIS 9001